An interventional study of repetitive transcranial magnetic stimulation- IDLPFC and repetitive transcranial magnetic stimulation - Six regions in Alzheimer Disease and Transcranial Magnetic Stimulation, sponsored by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente. Status unknown. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-09-01.
Sponsored by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente · Not applicable, Interventional, and Treatment
Randomized clinical trial, comparative and single blind aims to determine effects on cognition, psychological and behavioral symptoms and functionality of 5 Hz repetitive transcranial magnetic stimulation (rTMS) administered over left dorsolateral prefrontal cortex (lDLPFC) compared to six regions protocol, divided in two sub-conditions: day 1 (Broca area, Wernicke area and lDLPFC) alternated by day 2 (left and right parietal association cortex, and right dorsolateral prefrontal cortex [rDLPFC]). Main outcomes will be evaluated at ending of 15 rTMS sessions and 4 weeks after.
Alzheimer disease (AD) is a neurodegenerative disorder characterized by progressive cognitive decline that affects behavior and daily functionality. Its etiology is unknown and treatment efficacy is partial. Repetitive transcranial magnetic stimulation has been suggested as a potential treatment as of several trials has revealed improvements in language, episodic memory, psychological and behavioral symptoms in dementia as well as functionality using different experimental designs, stimulation parameters and cortical targets comparisons. However, it remains to determine the most effective modality, comparing outcomes with cortical targets poorly studied and how much the effects last. The main objective of this study is to determine which of two stimulation modalities provides a better cognitive and behavioral effect also on functionality in patients with potential diagnosis of AD, administered over lDLPFC (Condition A) and a six areas condition (Condition B) in which are alternated two sub-conditions (Day 1: Broca and Wernicke areas and lDLPFC, and Day 2: bilateral parietal association cortex and rDLPFC) along 15 sessions and 1500 pulses per session.
For this purpose, will be randomized 22 patients with potential diagnosis of AD (according to DSM-5) to both stimulation conditions (11 patients to each condition). The rTMS will be administered at 5 Hz and 1500 pulses per session (30 trains and 10 seconds inter-train interval) along 15 sessions with a post-treatment evaluation at 4 weeks comparing: time response, post-treatment effects and 4 weeks effects.
To evaluate clinical response among stimulation conditions will be used Alzheimer´s Disease Assessment Scale COGNITIVE (ADAS-cog), Cumming's Neuropsychiatric Inventory (NPI), Yesavage Geriatric Depression Scale (GDS), Interview for Deterioration-in-daily Living Activities in Dementia (IDDD) and Clinical Global Impression (CGI). The modified version of Mini Mental State (MMSE-FOLSTEIN) will be applied in the same time points of other evaluations also at the session 5 and 10. Other interest variables are: age, sex, civil status, education, occupation, time and type of pharmacological treatment.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 19 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente is the lead sponsor of 14 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Elimination criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Repetitive transcranial magnetic stimulation- IDLPFC. The intervention will be rTMS delivered on left dorsolateral prefrontal cortex (L-DLPFC). Every patient will receive 15 rTMS sessions (in weekdays) along three weeks at 5 Hz of frequency and at its 100% of motor threshold. Each session will consist of 30 trains separated by 10 seconds inter-train interval and 1500 total pulses per session. Equipment to rTMS includes a Magpro R30 stimulator (Magventure, Denmark) with an 8-shape coil model MCF-B70.
Device: repetitive transcranial magnetic stimulation- IDLPFC
Repetitive transcranial magnetic stimulation - Six regions. Two sub-conditions will alternate each session, starting with day 1: rTMS on Broca and Wernicke area and lDLPFC and then day 2: rTMS on left and right parietal association cortex (lPAC; rPAC) and right dorsolateral prefrontal cortex (rDLPFC). Patients will receive 15 intervention sessions (in weekdays) along three weeks at 5 Hz frequency and 100% of motor threshold. Each area will receive 10 trains (500 pulses) separated by 10 seconds of inter-train interval that correspond to 1500 total pulses per session. Equipment to rTMS includes a Magpro stimulator (Dantec, Denmark) with an 8-shape coil model MC-B70.
Device: repetitive transcranial magnetic stimulation - Six regions
Repetitive transcranial magnetic stimulation (rTMS) at 5Hz administered over left dorsolateral prefrontal cortex (lDLPFC). Repetitive transcranial magnetic stimulation (rTMS) at 5Hz administered over left dorsolateral prefrontal cortex (lDLPFC) compared to six regions protocol, divided in two sub-conditions: day 1 (Broca area, Wernicke area and lDLPFC) alternated by day 2 (left and right parietal association cortex, and right dorsolateral prefrontal cortex \[rDLPFC\]). Main outcomes will be evaluated at ending of 15 rTMS sessions and 4 weeks after.
Repetitive transcranial magnetic stimulation (rTMS) at 5Hz administered on six regions protocol, divided in two sub-conditions: day 1 (Broca area, Wernicke area and lDLPFC) alternated by day 2 (left and right parietal association cortex, and right dorsolateral prefrontal cortex \[rDLPFC\]). Main outcomes will be evaluated at ending of 15 rTMS sessions and 4 weeks after.
Changes on cognitive functioning (ADAS-cog)
ADAS-cog is cognitive testing instrument to measure severity. It explores 11 domains including memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD.
Time frame: Baseline, Post rTMS treatment: at week 3, and at week 4.
Changes on cognitive effects (Mini Mental State)
This instrument gives scores to orientation in time and space, registration information (three words) and recovering, attention, calculation, language (denomination, repetition, understanding of complex orders, reading and writing) and finally visuoconstruction (two overlapping diamonds).
Time frame: Baseline, every week for 3 weeks during rTMS treatment and at the 4th week after treatment.
Changes on behavioral symptoms (NPI)
This is a diagnostic instrument to determine the presence of behavioral symptoms. It measures frequency and severity of symptoms in the last month and the overload for the caregiver. This test divides behavioral symptoms in: delirium, hallucinations, agitation or aggressivity, anxiety, euphoria, apathy, irritability/lability, disinhibition, aberrant motor behavior, sleep and appetite/feeding.
Time frame: Baseline, Post rTMS treatment: at week 3, and at week 4.
Changes on depression symptoms (GDS-Yesavage)
Repeated application allows to evaluate changes in the geriatric depression evolution.
Time frame: Baseline, Post rTMS treatment: at week 3, and at week 4.
Changes on effects on functionality (IDDD)
This is an instrument designed to evaluate functionality in dementia. It evaluates self-care and complex activities.
Time frame: Baseline, Post rTMS treatment: at week 3, and at week 4.
Changes on Clinical Global Impression (CGI)
Standardized and descriptive scale, it gives qualitative information to identify changes in the illness through measuring severity of clinical picture and improvements triggered by treatments (change in the time) as well as treatment efficacy.
Time frame: Baseline, Post rTMS treatment: at week 3, and at week 4.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2016 to primary completion in Feb 2017, 11 months.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's 11 months is below that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente